Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator

This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.

Study Overview

• Status: Completed
• Conditions: Infertility; Abnormal Uterine Bleeding
• Intervention / Treatment: Device: Interlace Medical 1st Generation Hysteroscopic Morcellator

Detailed Description

A retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. Four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type I (mostly within the cavity) and type II (< 40% within the cavity) submucous myomas. Percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. Each of the four treating physicians also evaluated device performance using a 10 point scale (1 = "poor" and 10 = "excellent").

• Study Type: Observational
• Enrollment (Actual): 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator to resect intrauterine pathology (polyps and submucous myomas).

Description

Inclusion Criteria:

• female
• at least 18 years old
• treated for intra-uterine submucosal fibroids (Type 0 or 1 myomas and/or polyps using the Interlace 1st generation morcellator device.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Hysteroscopic Morcellator; 11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device.

Device: Interlace Medical 1st Generation Hysteroscopic Morcellator; The Interlace Medical hysteroscopic morcellator system has been cleared by the FDA(K073690)and consists of a motor drive unit connected to a 3mm morcellator. The morcellator is approximately 12 cm long and is equipped with an open channel that houses a reciprocating blade. When the motor is activated, the reciprocating blade will cut the tissue within the channel. The tissue travels down the 3mm morcellator shaft cannula via suction coupled to the proximal end of the morcellator and is captured in a tissue trap in a suction canister for pathological diagnosis following the procedure.; Other Names: MyoSure Tissure Removal System; MyoSure Tissure Removal Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Tissue Removed	mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.	immediately post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Time Per Patient	mean morcellation(division into and removal of small pieces, as of tissue) time per patient	at time of treatment
Fluid Volume Per Procedure	mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.	at time of treatment
Fluid Deficit Per Procedure	mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.	at time of treatment
Resected Tissue Weight Per Patient	mean weight of resected tissue per patient	at time of treatment
Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score	a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator("1" = "poor" and "10" = "excellent").	2-3 months post treatment
Adverse Events	Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study	2-3 months post-treatment

Collaborators and Investigators

• Sponsor: Hologic, Inc.
• Investigators: Principal Investigator: Charles Miller, M.D., Edward Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Estimate): November 22, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: hysteroscope; uterine fibroids; polypectomy; myomectomy; morcellator
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Infertility; Uterine Hemorrhage
• Other Study ID Numbers: TMP 200901